Access ports for injecting fluid into or removing fluid from a system, such as a drug vial, are well known and widely used. Conventional injection sites in drug vials generally involve a pierceable rubber stopper formed of an elastomeric material such as butyl rubber or the like, placed in the opening of the vial. A closure, typically formed of metal, is crimped over the rubber stopper and the flange of the vial to positively hold the stopper in place in the opening of the vial. The closure has an outer size, known as a “finish size.” The closure also has an opening, or access port, through which the stopper and the vial opening may be accessed. A sharp cannula is inserted into the access port piercing the rubber stopper to position the distal, open end of the cannula past the rubber stopper to make fluid connection with the interior of the vial. Such a configuration is useful when reconstituting a powder (i.e., adding a diluent or a liquid substance to a powder to make a solution, emulsion, or the like). A growing number of drug therapies are preferably stored and/or transported in a powder form and, accordingly, require reconstitution or mixing into a liquid substance prior to injection and delivery into a patient.
Adapters have been found useful in that they can adapt the sharpened cannula that is placed into fluid communication with the vial to the connection device of another fluid container or fluid delivery device such as a syringe. For example, the adapter may include a female Luer fitting opposite the sharpened cannula to receive the nozzle of a syringe. Luer connection systems are a standard way of attaching syringes, catheters, hubbed needles, IV tubes, and the like to each other. Luer connections consist of conical/tubular male and female interlocking components slightly tapered to hold together better. Luer connections can either be a “luer slip”, which are luer connections with a simple pressure or twist fit, or luer connections can be a “luer lock”, which can have an additional outer rim of threading allowing them to be more secure. The “adapter” therefore adapts the vial to the syringe, or adapts the sharpened cannula to the Luer-shaped nozzle of the syringe.
It has also been found useful to provide a means to attach or anchor the adapter to the vial to hold it in place while fluid communication between the vial and another device proceeds so that inadvertent disengagement of the adapter from the vial does not occur. For example, the adapter may have two arms that engage the neck or flange of the vial and hold the adapter in place on the vial. Other means include a shroud that fits around the outside of the vial closure and snaps onto the vial closure under the crimped retaining cap thereby grasping the vial neck flange and the underside of the closure.
However, some of the existing adapters available today suffer from various shortcomings. For example, most adapters are designed to function only on a single vial closure finish size. These adapters do not securely attach to vial closures with diameters smaller or larger than vial closure finish sizes they are primarily molded to fit. They are therefore not usable on vials of other sizes. In addition, some vial adapters do not adequately protect an operator from inadvertent puncture of the operator's skin by the sharpened cannula of the adapter. The shroud or vial engagement device does not extend completely over the sharpened cannula, thus exposing operators to possible puncture.
Accompanying this limitation of functioning with only a single size of vial, a further consideration is the expense to hospitals or other medical facilities caused by having to stock numerous types and sizes of adapters. Vials of many flange sizes and closure sizes are available and are frequently found in medical care facilities. Typically a hospital must stock a variety of adapters to be assured of having the correct adapter available that will properly interconnect with the multiple vial closures that exist. If a hospital must maintain a stock of adapters for each possible size of closure, a logistical problem as well as increased expense can result. Two common sizes of vial closures are 13 mm vial closures and 20 mm vial closures. Reducing the number of adapters that must be stocked in a hospital can significantly lessen the problems with stocking the correct sizes and can reduce expenses.
Certain vial adapters exist that can accommodate multiple sizes of vial closure finishes. Such adapters generally utilize an adapter skirt having a plurality of longitudinal slits. The skirt may have a flare configuration to accept vials of multiple sizes, with the longitudinal slits creating flexible arms. When the cannula is inserted through a cap of a vial, interior aspects of the flexible arms are configured to engage with the vial beneath the cap of the vial. Therefore, the adapter is retained in position on the vial, and because the arms are flexible, the adapter can be retained on vials having different vial closure diameters. However, a practical way to accommodate a range of vial finish sizes, including the large vial finish sizes which are increasingly common in industry, is needed. Hence, those concerned with the development of medical adapters have recognized the need for a single adapter that is usable with vials of different sizes.